Associate Director, MS&T

Solid Biosciences•Remote, Remote, US,

7h•$180,000 - $220,000•Remote

About The Position

Solid Biosciences is seeking an experienced and highly motivated Associate Director to be responsible for providing direct and detailed GMP manufacturing oversight for the company’s gene therapy products at external manufacturing partners. The ideal candidate will be able to apply strong depth of applied manufacturing sciences and technical project management to deliver all manufacturing preparations to meet quality requirements, while coordinating across internal and external stakeholders including Process and Analytical Development, Quality, Regulatory, and CDMO functions. This role will report to the Senior Director, MS&T and will be remote, requiring up to 25% travel at times.

Requirements

BS in science, engineering or equivalent with 10+ years of experience working in a related pharmaceutical environment. OR advanced degree (MS/PhD) with 8+ years of experience.
Demonstrated experience managing projects in the pharmaceutical industry.
Knowledge and experience working in accordance with cGMP, GDP, GCP, and ICH guidelines.
Experience engaging with external suppliers and partners, including CDMOs.
General knowledge of process development and pharmaceutical manufacturing for biologics including cell culture, purification, and/or fill/finish operations.
Strong interpersonal flexibility with ability to adapt to other personalities in a respectful manner that is conducive to the achievement of personal and team goals.
Excellent communication skills, both oral and written, which may include planning and execution of meetings and presentations.
Ability to multitask and handle multiple competing priorities and projects at once in a changing and fast-paced environment.
Strong analytical skills, strong oral and written communications skills, and the ability to work in new/unstructured environments.

Responsibilities

Partner with the Company Team including Manufacturing, Quality, AD/QC, Regulatory, and PD as a manufacturing SME for our clinical manufacturing processes and provide direct Person-in-Plant on-site support during, minimally, all critical cell culture, purification, and drug product unit operations at CMO production locations.
Drive GMP Compliance and evaluate all aspects of ongoing production and understand when to intervene on company’s behalf and when to escalate more significant issues for resolution.
Work in close collaboration with the CDMO and internal teams to support manufacturing investigations and change controls. Provide assessments of product and process impact and contribute to the identification of root cause and determination and development of appropriate action plans.
Review and/or approve CDMO manufacturing documentation including manufacturing bill of materials, production master batch records, and executed production record review.
Communicate routine production manufacturing status to company stakeholders and assist as necessary with process data retrieval, processing, analysis, through written, verbal, and presentation at various company meeting forums.
Author key technical documentation supporting manufacturing activities including technical risk assessments, manufacturing protocols, campaign reports, and descriptions of manufacturing process and controls.
Author supporting documentation for relevant CMC manufacturing content of various regulatory submissions as needed.

Benefits

Competitive Health and Dental programs with flexible plan offerings, including FSA and HSA programs
401(k) program participation with competitive company matched contributions
Eligibility to participate in Solid’s Employee Stock Purchase Plan
Mobile phone subsidy for eligible employees
Tuition Reimbursement
Vision Coverage
Life Insurance
Voluntary Pet Insurance
Employee Discount Program on Travel, Entertainment, and Services
Employee Assistance Programs
Daily Subsidized Lunch Delivery (onsite @ Hood Park)
Free Onsite Full-Service Gym (onsite @ Hood Park)
Employee Parking (onsite @ Hood Park)
12 Observed Holidays and a winter shut down
15-day PTO Policy and a 40-hour rollover YoY
40-hour Sick Policy
8 Hour Floating Holiday